FDA Adverse Event
Injury
Summary report: N
MILLENNIUM ANTERIOR MICROSURGICAL UNIT
MDR report key: 2792347
·
Received October 12, 2012
Report
- Report Number
- 1920664-2012-00197
- Event Type
- Injury
- Date Received
- October 12, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQC
- PMA / PMN Number
- K961310
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A B+L SERVICE TECHNICIAN INSPECTED THE SYSTEM AT THE FACILITY. THE SYSTEM WAS TESTED IN ALL DOCTOR MODES AND ALL READING MET SPECIFICATIONS. THE REPORTED PROBLEM COULD NOT BE CONFIRMED. REPORT 1 OF 2.
Description of Event or Problem · 1
A USER FACILITY REPORTED ASPIRATION VALUES IN THE MILLENNIUM UNIT ARE NOT CONSISTENT. ADDITIONAL INFORMATION: THERE WAS TRAMPOLINING IN THE EYE DURING A CATARACT PROCEDURE. AN UNPLANNED ANTERIOR VITRECTOMY WAS PERFORMED. THE REPORTER WAS UNABLE TO IDENTIFY THE EVENT THAT LED TO THE NEED FOR THE VITRECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLENNIUM ANTERIOR MICROSURGICAL UNIT | HQC | BAUSCH & LOMB, INC. | CX1110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |